FDA 483 - CMC Enterprise Pharmacy - March 22, 2019

The FDA inspection of the facility revealed multiple deficiencies in aseptic processing and quality control.

**Facility and Operations:** The ISO 5 classified aseptic processing areas contained difficult-to-clean, particle-generating, and visibly dirty equipment and surfaces. This included drywall, power strip ledges, open outlets, computer peripherals, taped paper towels, binders, office supplies, anti-fatigue mats, crumbling drywall, peeling paint, paper, and rust on HEPA filter covers, IV bag racks, table/cart legs, and office chairs. A white residue was also observed on various surfaces.

**Violations and Observations:** 1. **Aseptic Area Cleanliness:** ISO 5 areas had difficult-to-clean, particle-generating, and dirty surfaces (e.g., drywall, peeling paint, rust, office supplies). 2. **Air Quality Control:** Facility design allowed lower-classified air into the ISO 5 sterile production area due to simultaneous opening of doors to the gowning room and ISO 5 area, causing repeated pressure reversals during sterile drug production. 3. **Personnel and Material Flow:** The gowning room was inadequate for gowning and supply transfer, leading to personnel disregarding the line of demarcation and stepping over it without changing shoe covers. 4. **Material Disinfection:** IV bags were not individually sanitized; instead, they were piled and only the outermost surfaces were sprayed before entering the ISO 5 area. 5.